Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01569126 | A Study of LY110140 in Healthy Japanese Male Participants | PHASE1 | COMPLETED | 56 | — | — | Apr 1, 2012 | Sep 1, 2012 | Feb 10, 2014 | 1 | Japan |
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| 5 milligrams (mg) LY110140 (SD) | EXPERIMENTAL | 5 mg administered once in the fasted state on Day 1 |
| 20 mg LY110140 (SD) | EXPERIMENTAL | 20 mg administered once in the fasted state on Day 1 |
| 40 mg LY110140 (SD) | EXPERIMENTAL | 40 mg administered once in the fasted state on Day 1 |
| Placebo (MD) | PLACEBO_COMPARATOR | Placebo once daily oral dosing for 28 consecutive days |
| 20 mg LY110140 (MD) | EXPERIMENTAL | 20 mg once daily oral dosing for 28 consecutive days |
| 40 mg LY110140 (MD) | EXPERIMENTAL | 40 mg once daily oral dosing for 28 consecutive days |
| Name | Type | Description |
|---|---|---|
| LY110140 | DRUG | Administered orally as capsules |
| Placebo | DRUG | Administered orally as capsules in the placebo arm and to maintain the blind in the 20 mg LY110140 (MD) arm |
Inclusion Criteria: * Overtly healthy Japanese males (as determined by medical history and physical examination) who agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product. * Have a body mass index (BMI) of 18.5 to 29...